Method of using a surgical repair mesh

ABSTRACT

A mesh or fabric, having zero to variable stretch, is made from absorbable or partially absorbable fibers. The mesh or fabric can be either knitted or woven. The fabric is useful in surgical repair.

This is a continuation of application Ser. No. 604,104 filed Apr. 26,1984, now U.S. Pat. No. 4,633,873.

BACKGROUND AND SUMMARY OF THE INVENTION

This invention is concerned with a mesh or fabric which may be eitherknit or woven. The fabric is made from either a tissue absorbablematerial such as polyglycolic acid (herein PGA) fibers, or from apartially tissue absorbable material such as mixtures of PGA fibers andfibers of a nonabsorbable polyester or polyamide, or fibers of anothermedically acceptable nonabsorbable material. It is to be understood thatthe term polyglycolic acid is generic to both the homopolymer and tocopolymers containing a glycolic acid ester linkage.

The mesh or fabric has varying amounts of stretch, including zerostretch in the warp or in the weft (filling) direction.

The mesh or fabric may be useful in a wide variety of internal surgicalprocedures, e.g. as a tamponading device for pressure encapsulation andrepair of traumatically damaged organs such as the spleen, liver orkidney. The mesh or fabric may also be useful as a zero stretch or lowstretch material e.g. in the repair of an abdominal wall defect, hernia,urinary tract, etc. Further, the mesh or fabric may be useful in areasof the cardiovascular system and in the brain. Still further, the meshor fabric may be useful in oral surgery, for example to repair defectsand to encourage tissue ingrowth.

Although the dimensions and weight of the mesh are only limited by thepractical size for its intended use, dimensions of from 4×4 inches to10×13 inches and weights of 0.75 to 6.5 ounces per square yard can benormally used. Openings in the mesh can range normally from zero to 1/4inch. The mesh can also be manufactured as a tubular prosthesis.

A drawing which describes the shape and/or geometrical configuration ofthe mesh or fabric is not necessary for an understanding of thisinvention. That is, any person skilled in the mesh or fabric art willknow how to manufacture and how to use the invention by reading thisspecification, generally and the examples, specifically.

In order to further stabilize the fabric, that is to eliminatehorizontal or vertical edge curling and regulate stretch, the fabric maybe heat set by holding both length and width to a specified dimensionwithin a pin or clip frame while exposing the material to temperaturesof 90° to 175° C. for periods of 30 seconds to 15 minutes, preferably ina vacuum. The fabric may also be heat set by holding both the length andwidth to a specified dimension on a heated cylinder while exposing thematerial to temperatures of 90° to 175° C. for periods of up to 4 hoursin a vacuum.

A knitted surgical mesh has been invented. The mesh comprises aplurality of filaments. Each filament is manufactured from a polymerhaving a glycolic acid ester linkage. The filaments are bundled ortwisted into a yarn, and the yarn is knitted into a mesh.

In one embodiment, the polymer is a homopolymer. In another embodiment,the polymer is a copolymer. In a more specific embodiment, the copolymeris manufactured from glycolide and from trimethylene carbonate.

In yet another embodiment, the yarn manufactured from the homopolymer isgreater than about 60 denier and contains up to 4 plys. Each ply hasgreater than about 25 filaments. In a more specific embodiment, the yarnis up to about 150 denier, and the total number of filaments per yarn isup to about 75.

In still another embodiment, the yarn manufactured from the glycolideand trimethylene carbonate copolymer is about 65 to 85 denier. The yarncontains about 5 to 25 filaments.

In still another embodiment, the knitted mesh is manufactured on a 14gauge tricot knitting machine wherein the stitch design is

    ______________________________________                                        Front Bar        (2/0 2/4) × 2                                                           (4/6 4/2) × 2                                          and Back Bar     (4/6 4/2) × 2                                                           (2/0 2/4) × 2.                                         ______________________________________                                    

In yet another embodiment, the weight of the mesh is about 4 to 10oz./sq. yd. In a further embodiment, the quality of the mesh is about 10to 20 inches per 480 courses.

A knitted surgical fabric has also been invented. The fabric comprises aplurality of filaments. Each filament is manufactured from a polymerhaving a glycolic acid ester linkage. The filaments are bundled ortwisted into a yarn, and the yarn is knitted into a fabric.

In one embodiment, the polymer is a homopolymer. In another embodiment,the polymer is a copolymer. In a more specific embodiment, the copolymeris manufactured from glycolide and from trimethylene carbonate.

In yet another embodiment, the yarn manufactured from the polymer is upto about 150 denier and contains up to about 75 filaments. In a morespecific embodiment, the yarn is about 100 to 135 denier and containsabout 40 to 75 filaments.

In still another embodiment, the knitted fabric is manufactured on a 48gauge Raschel knitting machine wherein the stitch design is

Front Bar: 1/0 0/1

and Back Bar: 1/0 4/5.

In yet another embodiment, the weight of the fabric is about 4 to 10oz./sq. yd. In a further embodiment, the quality of the fabric is about10 to 20 inches per 480 courses.

A woven surgical fabric has been invented. The woven fabric comprises aplurality of filaments. Each filament is manufactured from a polymerhaving a glycolic acid ester linkage. The filaments are twisted into ayarn, and the yarn is woven into a fabric.

In one embodiment, the polymer is a homopolymer. In another embodiment,the polymer is a copolymer. In a more specific embodiment, the copolymeris manufactured from glycolide and from trimethylene carbonate.

In yet another embodiment, the yarn manufactured from the polymer isless than about 300 denier, and the yarn contains at least about 3 plys.In a more specific embodiment, the yarn is about 40 to 250 denier andcontains about 5 plys. The total number of filaments per yarn is about50 to 150.

In a still further embodiment, the warp yarn of the woven fabric hasabout 2 to 7 twists per inch and the filling yarn has about 1/2 to 5twists per inch. In a yet further embodiment, the weight of the fabricis about 1 to 6 oz./sq. yd.

DETAILED DESCRIPTION

The fabric of the invention can be either a knitted or a woven fabric.The fabric is of a medium weight.

One fabric of this invention, described more fully in Example 1 is astretchable knit mesh. The mesh can be manufactured on a 14 gauge tricotmachine, or alternatively on a 28 gauge Raschel warp knit machine usinga 2-bar construction. On either of these machines, the mesh is not heatset.

The yarn used in knitting the mesh can be between about 150 to 600denier with between 1 and 5 turns per inch of twist. Preferably, themesh has a lock stitch construction for nonravelling.

The usefulness of this fabric is primarily in the area of organ repair.Specifically, this fabric may be most useful in soft organ repair, e.g.,the spleen, liver or kidney. This fabric may also be useful in therepair of the pancreas. Finally, the utility of this fabric is as anorgan sling during internal healing of the organ. However, this fabriccan also be used as a retraction sling for other purposes, e.g. as aretraction sling for irradiation therapy.

Another fabric described in Examples 2 and 3 is a semistretchable knitmesh. It can be knit on a 28 gauge tricot machine using a 1-barconstruction. The mesh can be knit from a yarn having about 30 to 100denier.

The usefulness of this semistretchable knit mesh is in abdominal wallrepair, hernia repair, or in oral surgery, as a temporary support or asa packing material for encouragement of tissue ingrowth.

Another fabric of this invention, which is described more fully inExamples 4 and 5, is also a knit fabric. The fabric is heat set withoutstretching, and is stabilized. The heat set can be on a tenter frame.The fabric can be manufactured on a 24 gauge tricot or 48 gauge Raschelmachine using a 2-bar construction.

The fabric can be between about 75 to 250 denier with between about 1/4to 5 turns per inch. Preferably, the fabric is also manufactured using achain stitch for stability.

The utility of this fabric can be in abdominal wall repair. Other usescan be for the repair of diaphragm defects. Still other uses can be as arectal support for recurrent prolapse. Finally, the fabric may be usefulfor tracheal malacia.

Still another fabric of this invention, described in Examples 6 and 7,is a weave. The weave is stabilized. The fabric is manufactured on aloom.

The product is made from yarns of between about 150 to 350 denier. Thewarp yarn has between about 4 to 10 turns per inch of twist and the weftyarn has between about 1/4 to 5 turns per inch of twist. The weave canbe plain or it can have other configurations, e.g. twill or satin.Finally, the woven fabric has a water porosity of about zero to 1000ml/min/cm² at 120 mm of mercury.

Examples of typical fabrics or mesh as contemplated by this inventionare given below:

EXAMPLE 1 14 Gauge Tricot (14 needles/inch)

This example is a knitted mesh which has been neither stretched nor heatset.

(A) Stitch design:

Front bar: (2/0 2/4)×2, (4/6 4/2)×2

Back Bar: (4/6 4/2)×2, (2/0 2/4)×2

(B) Yarn description:

3 ply 110 den./50 fil. of polyglycolic acid (homopolymer)

(C) Fabric Weight:

5.0 to 7.5 oz./sq. yd.

(D) Fabric quality:

16 inches (per 480 courses)

EXAMPLE 2 28 Gauge Tricot (28 needles/inch)

This homopolymer example of a prior art glycolide and lactide copolymertight knitted mesh has been both stretched and heat set. Further theknitted mesh has been prestressed, i.e., stretched prior to heatsetting.

(A) Stitch Design:

Front bar: 1/0 1/2

Back bar: none

(B) Yarn description:

62 den./28 fil. of polyglycolic acid (homopolymer)

(C) Fabric weight:

1.00 to 2.75 oz./sq. yd.

(D) Fabric quality:

8 inches (per 480 courses)

EXAMPLE 3 28 Gauge Tricot (28 needles/inch)

This glycolide and trimethylene carbonate copolymer example of a priorart glycolide and lactide copolymer tight knitted mesh has been bothstretched and heat set. The stitch design is the same as Example 2.Further, the knitted mesh has been prestressed, i.e., stretched prior toheat setting.

(A) Stitch design:

Front bar: 1/0 1/2

Back bar: none

(B) Yarn description:

75 den./12 fil. of a glycolide and trimethylene carbonate copolymer.

(C) Fabric weight:

1.00 to 2.75 oz./sq. yd.

(D) Fabric quality:

8 inches (per 480 courses)

EXAMPLE 4 48 Gauge Raschel or 24 Gauge Tricot (24 needles/inch)

This example describes a knitted fabric which has been heat set but notstretched.

(A) Stitch design:

Front bar: 1/0 0/1 (chain stitch)

Back bar: 1/0 4/5

(B) Yarn description:

123 den./56 fil. of polyglycolic acid (homopolymer)

(C) Fabric weight:

6.25±.50 oz./sq. yd.

(D) Fabric quality:

14 inches (per 480 courses)

EXAMPLE 5 48 Gauge Raschel or 24 Gauge Tricot (24 needles/inch)

This example describes a knitted fabric which has been heat set but notstretched. The stitch design is the same as Example 4.

(A) Stitch design:

Front bar: 1/0 0/1 (chain stitch)

Back bar: 1/0 4/5

(B) Yarn description:

110 den./50 fil. of polyglycolic acid (homopolymer)

(C) Fabric weight:

5.85±.60 oz./sq. yd.

(D) Fabric quality:

14 inches (per 480 courses)

EXAMPLE 6 1×1 Plain Woven Fabric

This example teaches a woven fabric which has been neither stretched norheat set.

(A) Warp yarn and filling yarns: 5 ply 46 denier/21 fil. of polyglycolicacid (homopolymer)

(B) Warp yarn twist: 5 turns per inch

(C) Filling yarn twist: 1.5 turns per inch

(D) Fabric weight: 4.00±.50 oz./sq. yd.

EXAMPLE 7 1×1 Plain Woven Fabric

This example teaches a woven fabric which has been neither stretched norheat set.

(A) Warp yarn and filling yarns: 250 denier/50 fil. of a glycolide andtrimethylene carbonate copolymer.

(B) Warp yarn twist: 5 twists per inch

(C) Filling yarn twist: 1.5 twists per inch

(D) Fabric weight: 4.00±.50 oz./sq. yd.

We claim:
 1. A method of tamponading an organ in a warm blooded mammalcomprising:surgically opening the mammal; pressure encapsulating theorgan using a material manufactured from a stretchable, non-heat setknitted surgical mesh comprising a plurality of filaments, each filamentmanufactured from a polymer having a glycolic acid ester linkage, saidfilaments bundled or twisted into a yarn, and said yarn knitted into amesh; and surgically closing said mammal.
 2. A method of tamponading anorgan in a warm blooded mammal comprising:surgically opening the mammal;pressure encapsulating the organ using a material manufactured from achain stitched heat set knitted surgical fabric comprising a pluralityof filaments, each filament manufactured from a polymer having aglycolic acid ester linkage, said filaments bundled or twisted into ayarn, and said yarn knitted into a fabric; and surgically closing saidmammal.